BEUDAMED
    FDA Enforcement Class II Ongoing

    Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

    Recall: Z-1622-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1622-2023
    Event ID
    92238
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS HEADQUARTERS CAMBRIDGE
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2023
    Initiation Date
    April 12, 2023
    Classification Date
    May 23, 2023
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

    Reason

    Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

    Code Info

    UDI-Di: (01)00884838105508(21) Serial Numbers: 34053, 34092, 34164, 34168, 34179, 34195, 34200 (US) OUS: System Serial Number 34010 34020 34061 34070 34107 34108 34127 34142 34147 34157 34158 34161 34166 34176 34177 34178 34180 34194 34202 500453 500499 500501 500504 500506 500508 500511 500518 500529 550004 550023 550025 550034 550041 550052 550065 550069 550077 550079 550084 550086 550093 550103 550107 550114 550115 550119 550121 550128 550130 550140 550141 550150 550162 550164 550169 550174 550176 550181 550187 550188 550191 550194 550195 550203 550212 550234 550241 550248 550249 550251 550256 550266 550270 552038 552040 554023

    Distribution

    AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam

    Quantity

    7 units US and 76 unit OUS